BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82893 · Received February 27, 1997

    Report

    Report Number
    1527736-1997-00082
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    February 27, 1997
    Manufacturer
    EES - CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "WOULD NOT CUT" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE ITS FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING AN LAVH. THE 3RD AND 5TH FIRING OF THE TSW35 THE STAPLER WOULD NOT FIRE. ANOTHER TSW35 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW-UP: 2/4/97 1350 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 2/5/97 1715 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER GAG EES - CINCINNATI NA J45091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN